Rectal applicator

ABSTRACT

A rectal applicator for the administration of an enema as practiced in the roentgen examination of the intestinal tract, comprising a device formed by joining a tubular nozzle section with a tubular stem section. The device is provided at the junction of its two sections with an enlargement, the proximal face of which is formed with concentric annular ridges spaced from the nozzle tube and one another, and engageable against the perianal surface of a body to seal externally the anal opening. In one embodiment, the enlargement with the sealing ridges is integral with the nozzle section and the stem section is provided with an enlargement underlying and supporting the nozzle tube enlargement. In the preferred embodiment a chamber is formed at the junction between the two sections by joining them peripherally into a single structure, with the chamber serving to lend compressibility and adaptability to the device when applied in the depth of the cleft space against the perianal surface, and also serving to receive the contrast fluid.

United States Patent 1 1 Vass [451 Sept. 23, 1975 RECTAL APPLICATOR Alexander A. Vass, 309 E. 87th St., New York, NY. 10028 22 Filed: May 15, 1974 21 Appl. No.: 470,121

Related U.S. Application Data [76] Inventor:

[52] U.S. Cl. 128/245; 128/2 R [51] Int. Cl. A61M 3/00 [58] Field of Search 128/245, 239, 241, 247, 128/224, 248, 251, 2 R

[56] References Cited UNITED STATES PATENTS 2,644,451 7/1953 Sokolik 128/239 3,469,571 9/1969 Vass 128/245 X 3,469,575 9/1969 Vass et al. 128/245 3,575,160 4/1971 Vass et al. 128/245 X 3,577,982 5/1971 La Par 128/245 X Primary Examiner-Richard A. Gaudet Assistant ExaminerJ. Yasko Attorney, Agent, or FirmGottlieb, Rackman, Reisman & Kirsch [57] ABSTRACT A rectal applicator for the administration of an enema as practiced in the roentgen examination of the intestinal tract, comprising a device formed by joining a tubular nozzle section with a tubular stem section. The device is provided at the junction of its two sections with an enlargement, the proximal face of which is formed with concentric annular ridges spaced from the nozzle tube and one another, and engageable against the perianal surface of a body to seal externally the anal opening. in one embodiment, the enlargement with the sealing ridges is integral with the nozzle section and the stem section is provided with an enlargement underlying and supporting the nozzle tube enlargement. 1n the preferred embodiment a chamber is formed at the junction between the two sections by joining them peripherally into a single structure, with the chamber serving to lend compressibility and adaptability to the device when applied in the depth of the cleft space against the perianal surface, and also serving to receive the contrast fluid.

9 Claims, 10 Drawing Figures US Patent Sept. 23,1975 Sheet 1 of2 3,906,948

US Patent Sept. 23,1975 Sheet 2 of2 3,906,948

FIG. 9

FIG/0 1 REc'rAL APPLICATOR.

This application'is a continuation-in-part of applica- The present invention relates to an applicator for use i in administering cleansing or contrast enemas into the intestinal tract per rectum," and-, more particularly, to an applicator of the character described which is especially adapted for use on infants and babies.

The administering of enemas to infants and babies presents a number of problems because of the difficulty of immobilizingthe enema nozzle within the rectum,

and of preventing any leak-age or reflux of the fluid material. These difficulties arise because'of the inability of an infant-or small baby to cooperate. in retaining the nozzle within the rectum and'of gripping the rectum against it to prevent leakage, due primarily to the fact that small babies and infants have little or no control over the muscles, especially the sphincter-ani muscle.

Additionally, the rectums of infants and small babies have thin. and tender walls and are of relatively small cross-section and the application of an enema thereinto must be done with care and caution against injury to the rectal wall. I I

The instruments and procedure heretofore used in administering enemas to infants and small children have fallen short of overcoming the foregoing difficulties. One prior procedure involved the use of a flexible.

catheter whose end was inserted into the rectum and thereafter the infants tissues manipulated to press them closely against the catheter,.within the rectum, so as to avoid leakage and reflux. This is a time-consuming and frequently ineffective procedure for its purposes. Another instrument and procedure of the prior art involvedthe use of -an inflatable, tubular annulus commonly known as the balloon catheter, which is fitted aroundv the end of the applicator and pressed through the anus into the rectum with the applicator end. The annulus is thereafter inflated to press against the instrument tube and also against the intestinal walls. This procedure is likewise unsatisfactory for a number of reasons. The insertion of the collapsed annulus with the applicator end intothe rectumthrough an infants relatively narrow, anal opening is likely to be painful to the infant and may cause damage to theanal wall. Additionally, the inflation of the annulus in order for it to be effective to stop reflux must be ,done under relatively high pressure. This frequently causes rupture of the infantsrelatively thin and delicate rectal wall and can often prove fatal to the infant. Further, the inflated annulus must generally be disposed within the rectum a distance inwardly of its outer end. It therefore, in the case of barium enemas, prevents that portion of the rectum outwardly ofthe frontal .end of the inflated annulus from receiving the barium solution, so that that portion of the rectum cannot be opacified and therefore cannot be properly roentgenographically demon strated. I v

The prior art has also failed to mark properly the outer border of the infants anal canal duringabarium enema procedure. This function is important to allow the radiologist to ascertain where the diagnosti c region ends. The prior art provides a lead strip around the rearward portion of a catheter to thereby create an opaque marking on the X -r ay film. Butj th'is is not satisfactory for several reasons, most significantly because the lead ring'itselfis external to the catheter. This is not only costly, but is not as advantageous as utilizing the contrast fluid itself in an internal chamber of an enema applicator.

5 The present invention is directed to the provision of an applicator of the character described which is partieula rl y highly suitable for use on infants and which will overcome all of the foregoing shortcomings of the prior art devices and methods and will permit substantially paiiiless and refluxproof administration of fluid into the intestinal tract of infants and babies, perrectum, without any risk of damage or injury either to the anal opening or to the rectum and which will permit barium fluid to pervade the entire rectum and render all partsof it ppaque forroentgenography. This invention also provides an internal, marking chamber for receiving barium fluid so asjto idlentify theend ofthe diagnostic region. I i I It is also an object of the present invention to provide an applicator of the character described having all of the foregoing advantages which may be easily and rapidly applied with a minimum of pain and discomfort to the patient.

It is another object of the present invention to provide an applicator of thecharacter described which is, safe to use even in the smallest and tenderest of rectums.

It is still another object of the present invention to provide an applicator of the character described which,

when placed in fluid administering position on a body,

is substantially self-retaining in place on the body.

It is a further object of the present invention to provide an applicator of the character described which is highly effective for its purpose in sealing the anal opening against leakage and reflux even-with infants who cannot cooperate muscularly for that purpose.

It is a still further object of the present invention to provide an applicator of the character described which is relatively economical to produce and to discard after a single use. i

It is yet another object of this invention to provide a chamber within a re'ctal applicator for roentgenographieally marking the terminal anal opening during a barium enema examination. I

The foregoing and other objects and advantages of the applicator of the present invention will become more readily apparent to those skilled in the art from the several embodiments thereof shown in the accompanying drawing and from the description following. It is to be understood that such embodiments are shown by way of illustration only, tomake the principles and practice of, the invention more readily comprehensible and withoutany intentof limiting the invention to the specific details therein shown. In the drawings:

FIG. 1 is a vertical, sectional view of one embodiment of an applicator of the present invention;

FIG. 2 is a section taken substantially on line 22 of FIG. 1; i

FIG. 3 is an exploded. perspective view of the applicator-of FIG. 1;

FIG. 4 is a vertical, sectional view through a modified form of the applicator of the present invention;

FIG. '5 is aview illustrating the manner in which the applicator of the present invention is used for the administering of an enema to an infant;

FIG. 6 is a side view of another embodiment of this invention, illustrating a sagittal dependent plate beneath the posterior extension of the applicator;

FIG. 7 is a top view of the applicator of FIG. 6',

FIG. 8 is a side sectional view of the applicator of FIG. 6, taken along the line 88 of FIG. 7;

:FIG. 9 is a bottom view of the applicator of FIG. 6

and;

FIG. .10 illustrates the use of the applicator of the present invention in administering an enema to an infant and showing the use of the dependent plate in connection therewith.

Generally stated, the present invention contemplates the provision of an applicator for use, primarily, on infants and babies, which embodies the principle of sealing the rectum externally of the anal opening, as taught in U.S. Pat. Nos. 3,575,160 and 3,469,571, granted to applicant jointly with Clara Vass, and provides an applicator which combines the use of a body-entering nozzle section with a tubular stem section.

In the preferred embodiment, an enlargement of the stem portion is provided with a modified posterior extension formed by the combination of a horizontal plate with a sagittal plate. This combination represents a peripherally and therefore indirectly functioning anal sealing means adding to and'reinforcing the pressure to the anal opening of the centrally and directly acting sealing means of the tubular nozzle section. The body tissues to each side of the buttock cleft may be pressed and folded over the edges of the posterior extension and may, if desired, be connected by an adhesive tape or the like, to retain the applicator in rectum sealing position. When adhesive tape is applied to approximate the buttock cleft, pressure is exerted on the posterior extension by leverage applied to the sagittal depending plate. Force is thus transmitted to the centrally and directly acting sealing means, resulting in intensified and safer sealing.

Another advantage of the preferred embodiment of the applicator is the provision of a chamber which is formed between the tubular nozzle section and the stem section. This chamber comprises a central distally open largely cylindrical compartment and a peripheral and substantially annular compartment or recess. These compartments are connected by a narrow circumferential channel normal to the longitudinal axis of the applicator. The nozzle and stem sections are not directly and contiguously connected by the cylindrical compartment, with the circumferential channel being located between them.

In use, enema fluid passes into the marking chamber proximally from the tube of the stem section, and ultimately will enter the tube of the nozzle section for discharge into the rectum. In the course of following this travel path, some fluid will be diverted and will escape from the main stream through the channel coupling the cylindrical and annular compartments and will be captured in the peripheral annular compartment to provide opaque markings on the fluoroscopic screen or roentgenographic film, thereby acting as a helpful tool for diagnostic interpretation.

Referring in greater detail to the accompanying drawings, and with particular reference to FIGS. 1, 2 and 3 thereof, they show an applicator comprising a nozzle section, generally designated as 10, and a stem section, generally designated as 12. Nozzle section 10 is formed of a nonrigid, resiliently flexible material, as

a suitable relatively soft synthetic plastic material or rubber. It comprises a tubular. body entering, frontal portion 14 which widens at its distal end to provide a conical portion 18 formed with a depending flange 20. The stem section 12 is formed of a preferably rigid material, such as may be produced by the molding of a suitable, rigid-setting synthetic plastic, and consists of a tubular portion 22, having the bore 24 and whose proximal end 26 may fit snugly into the space defined by flange 20, where it may be cemented or otherwise adhered.

Surrounding the proximal end of tube 22 is a plate- Iike enlargement, generally normal to its longitudinal axis and generally designated as 28, having a thickened central portion 30 formed with an annular groove 32 surrounding the tube end 26 for receiving flange 20. The thickened portion 30 is formed with an upwardly and outwardly sloping surface portion 33, extending a short distance from groove 32, which is intersected by a depending wall 34 to form a sealing ridge 36 that is adapted to be pressed into the perianal region when nozzle is inserted into the rectum to form a seal for the anal opening. A second sealing ridge may be provided by a downwardly and outwardly sloping surface 38 extending from the base wall 34 which is intersected by an upwardly and outwardly sloping surface 40 that is intersected by a depending wall 42 to define a second sealing ridge 44 somewhat distally of ridge 36. Wall 42 defines the general outline of plate 28, except that it may be provided with an ovally tapered slightly frontally curved posterior extension 46.

In using the applicator of FIG. 1, nozzle 10 may be inserted into the rectum through the anal opening and pressed thereinto until ridges 36 and 44 come into contact with the perianal area to form a double seal surrounding the anal opening, the skin of the perianal area flowing into the depressions defined by and between the two ridges. It may here be stated that by spreading the buttocks to each side of the perianal area, the flattened surface is enlarged so that the outer ridge 44 effectively forms a seal. The applicator is so arranged that the elongation 46 extends posteriorly (see FIG. 5). The buttocks 50 overlap the edges of the enlargement 28 to maintain the applicator in place, and they may, additionally, be connected by an adhesive 52 to retain them in such overlapping position whereby the applicator is firmly held in place and the anal opening surrounded by a firm double seal.

It may be pointed out that, when inserting nozzle 10 into the rectum, its conical portion 18 will enter into the anus to reduce its outlet opening and thereby serve to enhance the effectiveness of the seal.

FIG. 4 illustrates a modified embodiment of the applicator of the present invention, wherein the thickened portion of the enlargement at the junction of sections 10 and 12, designated as 30a, is integrally formed with the nozzle tube 14 at its distal end, and is, therefore, of the same resiliently flexible material as tube 14. Enlargement 30a is preferably of substantially the same configuration as portion 30 of the embodiment of FIG. 1, and the sealing ridges or ribs 36a and 44a are formed integrally with enlargement 30a and arranged conformingly to the ridges or ribs 36 and 44 of the embodiment of FIG. 1.

The enlargement 30a is formed with a relatively shallow recess 54 in its underside at the center of which,

1 underlying tube I 4,':is aihigher 56 into which tube end 26 of stem 12 is set and cemented.

Stern tube 22 is provided with a radially extending plate 58 immediately below its frontal end 26. Plate 58 is formed with a raised central portion 60 on its frontal face which fits into and may be cemented within the shallow recess 54 on the underside of portion 30Z1and is provided with a downwardly and laterally offset flangel62 thatunderlies the parts of the thickened portion 30:: surrounding recess 54to therebyjforrn a rigidi fying base for the resiliently flexible portion 30a. The posterior extension 46 isuformed integr ally with plate 58. f

It will beapparentthat the applicatorernbodiment illustrated inFlG. 4, because, of the yieldable nature of sealing ridges or.ribs 36aand 44a, will cause a minimum of pain and irritation when applied against the perianal surface of an; infant or baby, without detracting from the sealing effectiveness of ridges 36a and Referring to FIGS. 6-9, a. modified and most preferred embodiment 'of the applicator of the present invention is illustrated comprising a tubular nozzle section, generally designated 63, and a tubular stem section, generally designated 64.-,Nozzle section 63 is formedof a non-rigid resiliently flexible material, as of a suitablerelatively soft synthetic plastic material or rubber. The section includes a'tubular body entering proximal position 64 which widens at its distal end to provide afrusto-conical portion 66, an enlarged directly sealing distal portion, generally designated 67, which is provided with sealing ridges 68 and 69. As shown in FIG. 8, the enlarged portion '67 is formed with an upper internal recess 70 which connects with the bore of the nozzle section tube by inlet opening 71 in the proximal end of recess 70. A second internal and largely annular recess 72 is formed in enlargement 67 and is located outwardly of recess 70, communicating therewith through lateral channel 73 which is formed I between the distal end of nozzle section 63 and the proximal end of stem section 64.

The tubular stem section 64 is formed of a preferably rigid material, such as may be produced by the molding of a suitable rigid-setting plastic, and consists of a tubular portion 74, having a bore 75. Surrounding the proximal end of the tube is a plate-like enlargement, gener ally normal to the longitudinal axis of the tube and designated 76, formed with an upper annular groove 77,

surrounding circumferentially the proximal opening of the tube of stem section 64.

It is noted that the barium contrast fluid will be introduced into the applicator through bore 75 of tubular portion 74. The fluid, introduced under slight pressure from a source, will pass from the distal towards the proximal portion of the applicator, following the path indicated by the longitudinal arrows in FIG. 8. When the contrast fluid reaches the central region of the applieator, namely the portion above the projecting cylindrical segment 74A of tubular portion 74, the flow of the fluid follows two different paths. While the principal portion of the fluid continues to travel longitudinally along the applicator and up through frusto conical portion 66 and tubular portion 65 of nozzle section 63, there is also a lateral flow of the fluid in a direction substantially normal to the longitudinal axis of the applicator. Thus, when the fluid reaches beyond the top of internal projection 74A of lower tubular portion 74, it thereby reaches lateral channel 73, and in view of thewell-known'physical principle that pressure is applied equally in all directions, the contrast fluid is cli rected along channel 73 and into upper annular recess 72 and lower annular groove 77. I

Ultimately, there will be sufficient lateral flow of the contrastfluid such that annular recesses 72 and 77 will become filled with the contrast fluid. The fluid will then resume its normal full flow along the longitudinal axis of the applicator as indicated by the upper arrow at the top oftube 65) until the operator terminates the introduction of the fluid into the applicator. The fluid which is then retained in annular recesses 72 and 77 will remain there throughout the diagnostic procedure, since it has no ready escape therefrom. Contrast fluid will alsorema'iri in central recess 70, just above'communication channel73. Wheii an X-ray or fluoroscopic examination of the patient is then conducted, the contrast fluid retained in recesses 72 and 77 will appear as a light region-on the film or screen. The region will also be wider in dimension than the portion of the fluid retained'further inward, for example that which is con tained within the. bore of tubular portion 65. This will create an opaque markingori the film or plate, defining for the diagnostician the level of the terminal opening of the anal canal and will permit the proper analysis and interpretation .of ,the results of barium enema examinations. The chamberand compartments also provide compressibility to section 67 to permit its adaptation to the variable resistances and tensions of the walls of the cleft space between the buttocl ts.

.The posterior extension of the enlargementof the stem section is provided with a horizontallplate 78 and a sagittal dependingplate 79. Plate 79 serves a dual function in applicants device, namely to provide auxiliarysealing and. also to facilitatemanipulation andorientation of the applicator. The significant advantage of sagittal plate 79 is the auxiliary scaling function which it provides when the applicator is positioned within a patient and connected to barium feeding tube 80, as illustrated in FIG. 10. When the applicator has been initially inserted, the buttocks 81 will be drawn towards each other by the operator, who will then tape the buttocks 81 together by means of adhesive tape 82. In so doing the approaching buttocks will apply an inwardly directed force (i.e., into the rectum as seen from the perspective of FIG. 10), tending to move the applicator further inward. However, because of the presence of enlargement 67 and posterior extension 78, the applicator cannot actually penetrate further into the rectum. Accordingly, the inwardly directed force applied to plate 79 will cause supplementary sealing pressure to be applied between applicants sealing ridges 68 and 69 against the perianal area. This serves to reinforce the basic external sealing achieved by applicants device.

This completes the description of the applicator of the present invention. It will be readily apparent that the applicators illustrated and described are highly effective and efficient for use for administering enemas to infants and babies in that, because of their yieldable and flexible nozzle portion, they may be inserted into the rectum without damaging either the rectal opening or the rectal walls and will cause a minimum of pain and discomfort to the patient. It will also be apparent that, because of the rigid stem thereof, the applicator may be manipulated with ease and dispatch. It will likewise be apparent that the applicator of the present invention will effectively seal the anal opening externally and that such seal will tend to be self-maintaining and its maintenance in place readily assured by the use of an adhesive band. Finally, applicants device also provides a marking chamber within its structure to thereby define the terminus of the diagnostic region for the operator.

lt will be further apparent that numerous modifications and variations may be made in the applicators of the invention, by anyone skilled in the art, in accordance with the principles of the invention hereinabove set forth and without the exercise of any inventive ingenuity.

What is claimed is:

1. An applicator for admininstering a fluid into the intestinal tract per rectum, comprising a tubular nozzle section and a tubular stem section joined to each other to form an integral structure, an enlargement formed at the junction of said nozzle and stem sections and extending normally to the axis of said integral structure, and a chamber within said enlargement to receive contrast fluid therein, and means on the proximal face of said enlargement adapted to be applied against the perianal area of a body into the rectum of which said nozzle is inserted to seal the anal opening thereof, said stern section having a posterior extension for providing indirect sealing of'said opening.

2. The applicator of claim 1, wherein said proximal face of. said enlargement is provided with at least one annular ridge surrounding and spaced from said nozzle section, said ridge adapted to be pressed into the surface of said perianal area.

3. The applicator of claim 2, wherein said enlargement is formedintegrally with said nozzle section and said stem section peripherally at said junction thereof, and said chamber is formed within said enlargement.

4. The applicatorof claim 3, wherein said posterior extension comprises a horizontal plate and a sagittal flange formed integrally with and depending from the distal surface of said horizontal plate and connected to said tubular stern section to provide proximal leverage for the sealing and immobilizing of said applicator in anal sealing position.

5. The applicator of claim 3, wherein said chamber within said enlargement is formed with a proximal inlet opening connected to said tubular nozzle section and with an opposite distal opening connected to said tubular stem section.

6. The applicator of claim 3, wherein said chamber formed within said enlargement comprises at least two compartments, a first of said compartments being centrally located and substantially cylindrical, and a second of said compartments being peripherally located and substantially annular.

7. The applicator of claim 6, wherein said first compartment extends normally to the axis of said tubular nozzle section and includes a proximal inlet opening connected to said tubular nozzle section, said first compartment having a greater diameter than that of said proximal inlet opening, and an annular depending flange defining the outer periphery and distal extent of said first compartment, said flange having a distal opening formed above and separated from the proximal end of said tubular stem section. 1

8. The applicator of claim 6, wherein said chamber includes said first compartment and said second compartment, and further includes a circumferential channel interconnecting said compartments, said channel extending normally to the longitudinal axis of said applicator.

9. The applicator of claim 6, wherein said circumferential channel is located between the distal opening of said first compartment and the proximal opening of said tubular stem section, said tubular nozzle section and said tubular stem section being separated by said circumferential channel, said second compartment adapted to receive said contrast fluid from said circumferential channel and said tubular stem section to thereby provide opaque marking for said applicator. 

1. An applicator for admininstering a fluid into the intestinal tract per rectum, comprising a tubular nozzle section and a tubular stem section joined to each other to form an integral structure, an enlargement formed at the junction of said nozzle and stem sections and extending normally to the axis of said integral structure, and a chamber within said enlargement to receive contrast fluid therein, and means on the proximal face of said enlargement adapted to be applied against the perianal area of a body into the rectum of which said nozzle is inserted to seal the anal opening thereof, said stem section having a posterior extension for providing indirect sealing of said opening.
 2. The applicator of claim 1, wherein said proximal face of said enlargement is provided with at least one annular ridge surrounding and spaced from said nozzle section, said ridge adapted to be pressed into the surface oF said perianal area.
 3. The applicator of claim 2, wherein said enlargement is formed integrally with said nozzle section and said stem section peripherally at said junction thereof, and said chamber is formed within said enlargement.
 4. The applicator of claim 3, wherein said posterior extension comprises a horizontal plate and a sagittal flange formed integrally with and depending from the distal surface of said horizontal plate and connected to said tubular stem section to provide proximal leverage for the sealing and immobilizing of said applicator in anal sealing position.
 5. The applicator of claim 3, wherein said chamber within said enlargement is formed with a proximal inlet opening connected to said tubular nozzle section and with an opposite distal opening connected to said tubular stem section.
 6. The applicator of claim 3, wherein said chamber formed within said enlargement comprises at least two compartments, a first of said compartments being centrally located and substantially cylindrical, and a second of said compartments being peripherally located and substantially annular.
 7. The applicator of claim 6, wherein said first compartment extends normally to the axis of said tubular nozzle section and includes a proximal inlet opening connected to said tubular nozzle section, said first compartment having a greater diameter than that of said proximal inlet opening, and an annular depending flange defining the outer periphery and distal extent of said first compartment, said flange having a distal opening formed above and separated from the proximal end of said tubular stem section.
 8. The applicator of claim 6, wherein said chamber includes said first compartment and said second compartment, and further includes a circumferential channel interconnecting said compartments, said channel extending normally to the longitudinal axis of said applicator.
 9. The applicator of claim 6, wherein said circumferential channel is located between the distal opening of said first compartment and the proximal opening of said tubular stem section, said tubular nozzle section and said tubular stem section being separated by said circumferential channel, said second compartment adapted to receive said contrast fluid from said circumferential channel and said tubular stem section to thereby provide opaque marking for said applicator. 